Markers of Oxidative Stress Present in Left Atrial Appendage Tissue in Patients With Atrial Fibrillation

September 26, 2013 updated by: Samuel C. Dudley, Jr., Emory University

Comparison of Markers of Oxidative Stress Present in Left Atrial Appendage Tissue From Subjects With and Without Atrial Fibrillation

The purpose of the study is to look at the differences between people who have irregular heart beats coming from the upper chamber of the heart (atrial fibrillation) compared to those who do not have these irregular beats.

Study Overview

Status

Terminated

Conditions

Detailed Description

Atrial fibrillation is an abnormal heart beat that starts in the upper parts of the heart and can cause stroke or death, if untreated. In general, treatments are not very effective with frequent relapses of the abnormal heart beats. One explanation for the high relapse rate is that the treatments might not address the underlying cause of atrial fibrillation.

Recently, we have found that atrial fibrillation is associated with increased oxidative stress in a particular part of the top parts of the heart, the left atrial appendage (LAA). Oxidative stress is a condition where abnormal oxygen forms are produced. These forms harm the cells of the heart, causing them to beat abnormally. Also, the inside of the heart becomes sticky and more likely to form blood clots. These clots, when they travel to the head, are thought to be the main cause of strokes in this condition. We have found increased oxidative stress and increased evidence of blood clotting in pig and mouse models of atrial fibrillation. We would like to see if these same findings are present in the human LAA.

In this study, we will compare blood and tissue markers of oxidative stress between patients with and without atrial fibrillation who are scheduled to undergo cardiac surgery. It is the expectation that participants with atrial fibrillation will have more abnormal markers of atrial fibrillation. This study requires participants to be seen during their routine preoperative visit, undergo a history and physical examination, give blood only once, and allow use of their discarded LAA. This tissue is routinely removed at surgery because its removal is thought to reduce the risk of strokes in patients who develop atrial fibrillation after the surgery. This happens in up to 50% of patients, thus providing the desire to remove the LAA.

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Georgia
  - Atlanta, Georgia, United States, 30322
    - Emory University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Male and females between 18 and 65 years of age who have irregular heart beats coming from the upper chamber of the heart (atrial fibrillation).

Description

Inclusion Criteria:

Cases must have atrial fibrillation documented on electrocardiographic recordings at the time of enrollment

Exclusion Criteria:

Younger than 18 and older than 65 years of age.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxidative Stress Time Frame: 1 year	Increased oxidative stress and increased evidence of blood clotting.	1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Investigators

Principal Investigator: Samuel C. Dudley, Jr., M.D., Ph.D., Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

October 24, 2005

First Submitted That Met QC Criteria